Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00886418
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2009-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Muscle Relaxation on a Closed-loop Anesthesia System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2009-04-19', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'propofol dose', 'timeFrame': 'one hour anesthesia'}], 'secondaryOutcomes': [{'measure': 'remifentanil dose', 'timeFrame': 'one hour anesthesia'}, {'measure': 'number of automatic modifications of the propofol and remifentanil concentrations', 'timeFrame': 'one hour anesthesia'}, {'measure': "number of patients' movements", 'timeFrame': 'one hour anesthesia'}, {'measure': 'number of hemodynamic abnormalities requiring treatment', 'timeFrame': 'one hour anesthesia'}, {'measure': 'time to wake up', 'timeFrame': 'end of anesthesia'}, {'measure': 'intraoperative awareness', 'timeFrame': 'postoperative day 1 or 2'}, {'measure': 'performance of the closed-loop system', 'timeFrame': 'one hour anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia, General']}, 'descriptionModule': {'briefSummary': 'Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for a surgical procedure which not require a myorelaxation\n\nExclusion Criteria:\n\n* age less than 18 years,\n* ASA III and above,\n* pregnant woman\n* combined general and regional anesthesia,\n* history of prolonged myorelaxation due to a decrease in cholinesterase,\n* patient with a known lack in cholinesterase,\n* history of cerebral or psychiatric central,\n* allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,\n* known hypersensitivity to remifentanil or to an other derivative of fentanyl,\n* presence of a pacemaker,\n* psychotropic or agonist-antagonist morphine treatment,\n* planned post-operative sedation.'}, 'identificationModule': {'nctId': 'NCT00886418', 'acronym': 'Drone-Curare', 'briefTitle': 'Influence of Muscle Relaxation on a Closed-loop Anesthesia System', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)', 'orgStudyIdInfo': {'id': '2008/28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia.', 'interventionNames': ['Drug: muscle relaxant']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'muscle relaxant', 'type': 'DRUG', 'description': 'muscle relaxant administration throughout anesthesia', 'armGroupLabels': ['1']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'no muscle relaxant throughout anesthesia (normal saline infused as a placebo)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmette', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}